ND-YAG Laser Iris Depigmentation for Cosmoses

April 29, 2025 updated by: Elshimaa A.Mateen, Sohag University
Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session.

visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Elshimaa A.Mateen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • clear cornea
  • clear lens
  • normal IOP < 20 mmHg
  • adults aged more than 18 years old
  • normal fundus
  • dark pigmented iris (black or brown)

Exclusion Criteria:

  • Glaucomatous patients and those receiving anti-glaucoma treatment.
  • corneal or lens opacity.
  • any fundus abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ND-YAG Laser for iris depigmentation
Device: Nd-YAG Laser for iris depigmentation
Nd-YAG Laser for iris depigmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation
Time Frame: one year
Session of Nd-YAG Laser targeting the iris using power less than that used for peripheral iridotomy causing pigment bleaching to change the iris colour for cosmoses, which may cause pigmentary glaucoma (secondary open angle glaucoma).
one year
Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser
Time Frame: one year
If ND-YAG LASER could affect visual acuity.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NILES-EC-CU 23/7/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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